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Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS).
Yerton M, Winter A, Gelevski D, Addy G, Kostov A, Lieberman C, Weber H, Doyle M, Kane G, Cohen C, Parikh N, Burke KM, Rohrer M, Stirrat T, Bruno M, Hochman A, Luppino S, Scalia J, D'Agostino D, Sinani E, Yu H, Drake K, Hagar J, Sherman AV, Babu S, Berry JD, Cudkowicz ME, Paganoni S. Yerton M, et al. Among authors: sherman av. Muscle Nerve. 2023 Jun;67(6):456-463. doi: 10.1002/mus.27819. Epub 2023 Apr 5. Muscle Nerve. 2023. PMID: 36929648
Safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis: a multi-stage, randomised, double-blind, placebo-controlled trial.
Cudkowicz ME, Titus S, Kearney M, Yu H, Sherman A, Schoenfeld D, Hayden D, Shui A, Brooks B, Conwit R, Felsenstein D, Greenblatt DJ, Keroack M, Kissel JT, Miller R, Rosenfeld J, Rothstein JD, Simpson E, Tolkoff-Rubin N, Zinman L, Shefner JM; Ceftriaxone Study Investigators. Cudkowicz ME, et al. Lancet Neurol. 2014 Nov;13(11):1083-1091. doi: 10.1016/S1474-4422(14)70222-4. Epub 2014 Oct 5. Lancet Neurol. 2014. PMID: 25297012 Free PMC article. Clinical Trial.
The PRO-ACT database: design, initial analyses, and predictive features.
Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, Walker J, Katsovskiy I, Schoenfeld D, Cudkowicz M, Leitner M. Atassi N, et al. Neurology. 2014 Nov 4;83(19):1719-25. doi: 10.1212/WNL.0000000000000951. Epub 2014 Oct 8. Neurology. 2014. PMID: 25298304 Free PMC article.
Being PRO-ACTive: What can a Clinical Trial Database Reveal About ALS?
Zach N, Ennist DL, Taylor AA, Alon H, Sherman A, Kueffner R, Walker J, Sinani E, Katsovskiy I, Cudkowicz M, Leitner ML. Zach N, et al. Neurotherapeutics. 2015 Apr;12(2):417-23. doi: 10.1007/s13311-015-0336-z. Neurotherapeutics. 2015. PMID: 25613183 Free PMC article. Review.
How common are ALS plateaus and reversals?
Bedlack RS, Vaughan T, Wicks P, Heywood J, Sinani E, Selsov R, Macklin EA, Schoenfeld D, Cudkowicz M, Sherman A. Bedlack RS, et al. Neurology. 2016 Mar 1;86(9):808-12. doi: 10.1212/WNL.0000000000002251. Epub 2015 Dec 9. Neurology. 2016. PMID: 26658909 Free PMC article. Clinical Trial.
A randomized trial of mexiletine in ALS: Safety and effects on muscle cramps and progression.
Weiss MD, Macklin EA, Simmons Z, Knox AS, Greenblatt DJ, Atassi N, Graves M, Parziale N, Salameh JS, Quinn C, Brown RH Jr, Distad JB, Trivedi J, Shefner JM, Barohn RJ, Pestronk A, Swenson A, Cudkowicz ME; Mexiletine ALS Study Group. Weiss MD, et al. Neurology. 2016 Apr 19;86(16):1474-81. doi: 10.1212/WNL.0000000000002507. Epub 2016 Feb 24. Neurology. 2016. PMID: 26911633 Free PMC article. Clinical Trial.
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